Boehringer Ingelheim has reported positive data from two clinical trials that investigated dabigatran etexilate, a direct oral anticoagulant (DOAC), for the treatment and prevention of recurrent venous thromboembolism (VTE) in children.
In the Phase IIb/III DIVERSITY trial, dabigatran was found to be effective and demonstrated a safety profile comparable to the current standard of care (SOC) for acute VTE treatment in children.
A second Phase III study also showed a favourable safety profile for the prevention of recurrent VTE in children having persistent VTE risk factors.
The goal of the trials was to gather data about anticoagulation in paediatric patients with VTE, or at risk of recurrent VTE, said Boehringer.
Boehringer Ingelheim Cardiovascular, Cardiometabolic Medicine clinical development global head Martina Brückmann said: “Although treatments are currently available to help manage VTE, there is still a need for effective, safe and more convenient options that have been investigated in children.
“We therefore wanted to assess if dabigatran’s established safety and efficacy, in treating adults with VTE, also translated through to paediatric patients. It is therefore encouraging that these studies suggest a comparable safety profile and efficacy for dabigatran for the potential treatment and prevention of recurrent VTE in children.”
The company added that dabigatran’s safety and efficacy in adults has been validated in the RE-VOLUTION clinical trial programme.
DIVERSITY is an open-label, randomised, multi-centre, Phase IIb/III study that compared the efficacy and safety of dabigatran to that of SOC. The trial enrolled patients under 18 years old who have acute VTE and need anticoagulation therapy for three months.
Results showed non-inferiority of dabigatran to SOC, with comparable bleeding rates.
In the second open-label, single-arm, prospective cohort Phase III trial, around 200 children were treated with dabigatran for up to 12 months to prevent secondary VTE.
According to the findings, Boehringer’s drug led to a low overall frequency of recurrent VTEs and any major bleeding events, indicating a favourable safety profile.